Saturday, March 28, 2015

Second Imposition Of Three Day "Stay At Home" Orders Underway In Sierra Leone, Tonight

We here in our lil' shop continue to search the newswires diligently, for any signs of good news on the current and unspeakably tragic Ebola outbreak. Along those lines, we do know that the Phase II trials in Guinea have moved into Phase III -- that is, the scientific consensus now holds that the vaccine candidates are completely safe. And so, the studies will henceforth focus on durability of the immune responses, going forward.

Against the backdrop of that rather hopeful news, we learn that Sierra Leone has imposed (for a second time) a three day ban on unneeded movement, for all her 6 million citizens. The idea is to avoid complacency -- and continue to focus awareness on safe practices. Difficult times. . . require difficult measures. Here is the "Beeb" (BBC) on it all:

. . . .This lockdown comes amidst some rare good news. According to official figures from the World Health Organization, there were just 33 new confirmed cases last week - the lowest number since June 2014.

But with these falling figures there is danger of growing complacency, the government says.

This is one of the main reasons behind the lockdown - volunteers will remind people how to protect themselves against a virus that is still a real threat.

They will focus their efforts on northern and western areas where some infections still come as a surprise to officials - 16% of cases last week were not known Ebola contacts.

Experts have criticized previous stay-at-homes as too heavy-handed and top-down in their approach. Concerns were raised that some people did not have access to food.

The hope is, a year after the outbreak was declared, such logistical problems have been ironed out and that this measure will bring the country closer to its goal of zero Ebola infections by April 15, 2015 - an ambitious target that is just two weeks away. . . .

Sleep tight, one and all. And if you are so inclined, do ask the Infinite for some support here (I myself am bound by a differing covenant). Yes, tomorrow is another day.

Friday, March 27, 2015

Merck Q1 Results: April 28, 2015 -- Before NYSE Opens

We will tune in on that morning.

. . . .Merck will hold its first-quarter 2015 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, April 28. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at A replay of the webcast will be available at approximately 11:00 a.m. EDT on April 28 and will remain on the website for 12 months. The sales and earnings news release and supplemental financial disclosures also will be available in the Newsroom and Investor sections of the company’s website. . . .

Have a great weekend, one and all!

Wednesday, March 25, 2015

UPDATE: At Least Until April 28, 2015, Glenmark May Continue To Manufacture And Sell Generic Sitagliptin In India -- Supreme Court Of India

In an update to our coverage of last week, the Indian news-wires are reporting this morning that the Supreme Court of India has granted Glenmark a stay on the injunction -- through April 28, 2015 -- when their Supremes will hear the Glenmark appeal. That means Glenmark is free to keep selling its "at risk" generic sitagliptin in India (a right the High Court allowed, in any event, to sell off Glenmark's existing inventory).

I am uncertain about this, but it would surprise me if Glenmark didn't already have enough inventory on hand to keep shipping through April 28, 2015. In the event that it does not, it is now free to manufacture enough to reach that date. Glenmark may still have to pay Merck a royalty on all these sales, but the people of India may still source cheaper generics from Glenmark. Here's a bit, locally:

. . . .Supreme Court today stayed util April 28 the order of Delhi High Court barring Indian pharma major Glenmark Pharamceuticals from making, marketing or selling its anti-diabetes medicines in which US drug major Merck Sharp and Dohme (MSD) has claimed patent right.

"Up to April 28, there will be an interim stay on the order of the High Court," a bench comprising Justices Ranjan Gogoi and N V Ramana said. . . .

So, even if the Indian Supreme Court decides that the High Court's injunction will stand -- Glenmark will likely only ever owe Merck a running royalty on sales -- through the date of that decision. I do think the Supremes will ultimately enjoin Glenmark, and effectively force it to buy a license from Kenilworth, but I expect that generic sitagliptin therapies, from either "authorized generic" sources -- or Glenmark and Aprica -- i.e., non-authorized sources. . . are here to stay, in India. Merck has tacitly acknowledged this fact, by reducing its own pricing in country, since 2014.

Tuesday, March 24, 2015

Merck Replenishes Stock Repurchase Program -- Incremental $10 Billion Equal To May 2013 Authority

Just as it did in May of 2013, Merck has once again added an incremental $10 billion of stock buyback authority, tonight, after the NYSE closed for the day.

A more jaundiced viewer might ask whether Kenilworth cannot find some higher -- internal rate of return on capital hurdle exceeding -- use for that $10 billion of capital, now deployed to the pockets of shareholders wishing to get liquid. Afterall, "investing" in a buyback just exactly meets one's cost of internal equity capital. True enough -- it won't drag the return rate down -- but it doesn't bump it up, either.

And that is a fair view. Moreover, shareholders don't mind the soft support a buyback program of size offers, should there be an anomalous dip in the NYSE price, on a temporary basis. Then the stock repurchase program can kick in -- and act as gentle slow support to the price.

I do wonder though whether Merck might see a higher return on that capital, longer term, by investing more in a Keytruda trial/launch in yet another cancer. Here's a bit, from PharmiWeb simply parroting the presser from Kenilworth:

. . . .With today’s announcement the company’s total outstanding share repurchase authorization is now approximately $11.7 billion which includes approximately $1.7 billion in authorized repurchases remaining under the program previously announced on May 1 2013.

Merck continues to expect average diluted shares outstanding will be approximately 2.86 billion in 2015. . . .

So -- I'd look for a mild price rise, in the coming weeks -- or at least less erosion than the general DJIA experiences, due in no small part to the cushion of a replenished $10 billion repurchase program.

Doctors Without Borders Report: Last Week, The Ebola Outbreak Turned One. . .

However. . . rather than dwell on all the quite accurately-reported problems with the global response to this outbreak, from Doctors Without Borders, I'll choose to highlight two old, but promising, antiviral agents that seemed to work, in at least a few post contraction human cases, to arrest progression of the hemorrhagic virus. [See graphic at right, and the European Community statements here.]

I suppose the enduring tragedy of it all will turn out to be that there was no need for the outbreak to see its first birthday. Had we, collectively, made finishing this vaccine candidate (long ago discovered in Canada) a priority, the outbreak may well have ended in just a few months -- and not have claimed upwards of 11,000 lives. In any event, here is a bit from Wired, this morning:

. . . .Last week, the Ebola epidemic in West Africa achieved its first birthday. Though the viral outbreak has been contained, it is still not under control: According to the World Health Organization, cases continue in Sierra Leone and are rising again in Guinea. Liberia was about to record an entire incubation period without a new case — a signal that the chain of person-to-person transmission might have been broken — but on Friday, it announced that it had found a single new case. How that woman became infected is unclear; it is possible that she represents, not a new outbreak, but a brief interruption in an otherwise promising trend.

It has been decades since there was an epidemic of this persistence and magnitude. No other Ebola outbreak matches it; nor does the 2003 epidemic of SARS. You would have to go back to the early days of HIV in the 1980s, or to the flu pandemics in 1968, 1957 or even 1918, to find an outbreak that sickened so many people, challenged international response capacity so much, and instilled such fear in other countries. . . .

Even so, with at least two vaccine candidates showing promise, and these antiviral agents, we may be just a few steps away from turning the corner, here. Onward.

Good News -- But Unsurprising -- Pembrolizumab (Keytruda®) Is An Effective First Line -- In Melanoma

I'll highlight it here, because it adds to the thesis: Anti PD-1 immuno approaches are the wave of the future -- in many, many cancers.

Good news, for Kenilworth, and cancer patients. The high burden disease states await. Here's the Merck presser:

. . . .[Merck] today announced that the randomized, pivotal Phase 3 study (KEYNOTE-006) investigating Keytruda® (pembrolizumab) compared to ipilimumab in the first-line treatment of patients with advanced melanoma has met its two primary endpoints of progression-free survival and overall survival. The trial will be stopped early based on the recommendation of the study’s independent Data Monitoring Committee. . . .

Enjoy a productive Tuesday now, one and all.

Saturday, March 21, 2015

Some Sad News Concerning Liberia; Even As "Ring" Ebola Vaccine Candidate Trials Continue for Merck, In Guinea

As is so often true, out in the wild, biological life forms just. . . find a way. They adapt. They evolve. Just as we all inexorably do. But we will certainly hope that these viral agents do not mutate -- not too quickly, nor too radically, this time around.

This is all a stark reminder that all science is only as good as the biology that supports it. I suppose I should, on a positive note, remark that in Guinea the large scale "ring" trials of Merck and NewLink, as well as those of GSK, continue to enroll robustly (due in no small part to a series of payments, roughly equal to ten-weeks' full-time wages, to recruit volunteers in-country). It would be reassuring to know that we -- as a planet -- have a safe, effective vaccine or two in hand, as these outbreaks reappear. [And if history has taught us anything, it is that they will reappear.]

But for now, we will worry that it evolves or mutates before it can be tamped down. Here is the latest bit, out of Monrovia (Liberia's capital city), from DM Akadamie -- do go read it all:

. . . .Officials in Liberia were scheduled to meet in an emergency session on Saturday in the latest chapter of the Ebola epidemic.

The cause of the meeting was announced the evening before when health officials confirmed that a woman in the capital city Monrovia had been diagnosed with the hemorrhagic virus.

"This is a new case after we have gone more than 27 days without a single case. It is a setback," government spokesman Lewis Brown said.

The last confirmed Ebola patient in Liberia was discharged from hospital on March 5, prompting a 42-day countdown to begin until the West African country could be declared free of the fatal disease.

Since the outbreak of the epidemic in December 2013, the United Nations has counted over 10,000 Ebola-related deaths, nearly all of which occurred in across Liberia, Guinea and Sierra Leone. Health officials, while hopeful that Liberia would report no new cases by mid-April, remained aware of the threat posed by the neighboring West African nations still crisis-ridden. . . .

With this bit of disheartening news, we will look forward to a quiet and reflective Sunday, here. So it goes.

Friday, March 20, 2015

Januvia® Patent Litigation In India Continues -- Over "At Risk Launched" Generic Sitagliptin (-Phosphate) -- But Merck Wins A Round

We've been waiting for a little over 21 months for clarity on this request for an injunction by MSD India, the local Merck & Co. affiliate there.

This very morning, as various and sundry Indian news outlets are reporting -- the Delhi High Court three-judge panel has granted Merck an injunction, keeping any new inventory of the Glenmark generic form of sitagliptin off market there. However, Glenmark will be allowed to sell out its existing inventory of Zita and Zita-met, the knockoffs of Januvia®, and Janumet®.

As we first reported in June of 2013, MSD India was granted a similar order, barring another generic maker -- Aprica -- from selling a generic form of sitiagliptin phosphate in India.

. . . .The Delhi high court on Friday restrained Indian firm Glenmark Pharmaceuticals from manufacturing, marketing or selling its anti-diabetes drugs Zita and Zita-Met, saying it has “prima facie” infringed the patent of US drug major Merck Sharp and Dohme (MSD). . . .

The court also set aside its single-judge’s 5 April 2013 order refusing to restrain Indian company from manufacturing and selling its medicines meant for treatment of Type-2 diabetes. . . .

The bench, however, on Glenmark’s oral plea to allow it to sell its goods already in the market, clarified that it “may sell such of the products which are already in the market i.e in possession of its distributors and retailers”. . . .

I still think there will be a global settlement here, with all the generic makers -- since diabetes represents such a high-burden disease in the relatively limited means populations of India. But we will keep you apprised.

For now, Merck has been able to take another extremely low price alternative off-market in India. Even so, Merck sells its own branded sitagliptin (Januvia) at a big discount in India, compared to what it charges in the US, and EU. On a global basis, the company's sitagliptin sales growth (in dollars) has slowed for Kenilworth, since mid to late 2014, in part due to these factors we have been steadily covering. Now you know. [NB: Weekend outage alert -- traveling and out of pocket.]

Wednesday, March 18, 2015

Merck Shares Rise 2 Per Cent -- After Announcing "Late-Breaking" NSCLC Keytruda® Data Presentation: Mid April 2015

While we don't yet know how the data reads out, we may infer fairly safely that it will put Kenilworth in the hunt for an NSCLC FDA label expansion/approval -- on Keytruda® -- in late 2015 or early 2016. And that is a good thing, given the immense burden that lung cancer represents -- as a disease state.
Expect more later, as I am road-blogging here. Here is a bit from the press release, out of Kenilworth at around 4 PM EDT today:

. . . .The NSCLC data will be the first presentation of new efficacy and safety findings for KEYTRUDA from 495 patients, including validation of PD-L1 expression (abstract #CT104). These data are from the largest, multi-center Phase 1b (KEYNOTE-001) study of an anti-PD-1 therapy. With the mesothelioma findings (abstract #CT103), data evaluating KEYTRUDA will have been presented in eight different types of cancer. . . .

Graphics will follow. Even if the NSCLC data doesn't allow for/get granted a priority review at FDA, this is materially good news. Maybe Merck is now only six to nine months behind BMS -- maybe. Not nine to twelve. And maybe a little under six, if FDA grants Merck a priority review designation. We shall see.

Monday, March 16, 2015

WHY Leerink Swann Reduced Its Merck Target To $62.50, From $66 -- Fernandez's Latest Opdivo® Analysis

In a word -- BMS's Opdivo®.

It seems Seamus Fernadez agrees with us: Merck's Keytruda® fortunes are at least marginally worse (albeit in a slightly material fashion), post the news of eleven days ago. Here is a bit, from the Leerink key take-aways, at that firm's 2015 conference on global healthcare. Do go read it all:

. . . .Off-label reimbursement [for BMS's Opdivo] has been challenging to date, but the KOL believes that lung cancer approval in one setting paired with the available scientific publications and abstracts should drive reimbursement across multiple lines of therapy or histologies. Both physicians believe that 2nd line approval of PD1/ PDL1 could change the progression from 1st to 2nd line therapy such that the discontinuation rate between 1st and 2nd line treatment could be much less than the frequently cited 50%.

In addition, it was suggested that savvy physicians could employ a “fast-fail” strategy with chemotherapy in order to more quickly start patients on these life-saving drugs. One KOL noted a similar strategy with Zytiga (abiraterone) which broadened use earlier than most expected. . . .

Opdivo [is] expected to quickly replace Afinitor in 2nd line kidney cancer; assumes success of BMY’s -025 study. The genitourinary specialist (prostate, kidney) was confident that BMY’s Opdivo would best Afinitor in the head-to-head 025 study largely because Afinitor is such a poor treatment standard. He predicted that once available, Opdivo will quickly replace 100% of Afinitor use in kidney cancer. He noted, however, the need for combination therapy to demonstrate improved overall survival vs. 1st line VEGF TKIs.. . .

Sleep well, now one and all!

Sunday, March 15, 2015

The Week That Was: Jefferies Still See-Sawing On Merck

I suspect this slight down-beat was due to BMS's Opdivo® receiving an FDA lung cancer (NSCLC) nod, during the past ten days. It marginally erodes Merck's market cap potential. But only marginally.

Jefferies' Seamus Fernandez is unlikely to alter his views very much on Merck, or BMS (or J&J, for that matter) in the near term. He has bounced it around, quite a bit, from $65 to $60 -- with one stop north of there, only -- in the last 24 months. Here's a bit, from a reprint of an earlier time:

. . . .Jefferies Group has also taken action a number of other healthcare stocks recently. The firm lowered its price target on shares of Merck & Co., Inc. from $63.00 to $62.00. They have a hold rating on that stock. Also, Jefferies Group raised its price target on shares of Johnson & Johnson from $108.00 to $110.00. They have a hold rating on that stock. . . .

So -- really no news at all. And so, we waited until Sunday morning to note it, casually, over coffee, juice and a banana.

Saturday, March 14, 2015

O/T, But Only Once A Century -- Epic Pi Day 3.141592653!

Well, I suppose it belongs here -- because of its importance to all of the life sciences, generally. And -- as someone I love told me yesterday -- I'm a goof for it. True -- but my adoration of it is. . . shameless.

From The New York Times opinion page, this afternoon, then:

. . . .Early mathematicians realized pi’s usefulness in calculating areas, which is why they spent so much effort trying to dig its digits out. Archimedes used 96-sided polygons to painstakingly approximate the circle and showed that pi lay between 223/71 and 22/7. By the time Madhava (in India, around 1400) calculated pi to over 10 decimal places using his groundbreaking infinite series (which regrettably bears Leibniz’s name), it was already more than accurate enough to address all practical applications. Pursuing pi further had essentially become a mathematical challenge. . . .

I just had a big slice of warm pecan pie, literally swimming in dollops of whipped cream. . . so my celebration and observance is. . . complete! Have you. . . had yours?

Friday, March 13, 2015

I Hate Being Right About This Kind Of Stuff: Bridion® -- No St. Paddy's Gift -- At FDA

Buried on a Friday afternoon before St. Patrick's. . . .

I'll have more in a few minutes, but this former Fast Fred "Star" just cannot catch a break. The review at an Advisory Committee of FDA next week was just. . . scrubbed. Pulled. Dumped. From Kenilworth's presser, then:

. . .The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101). The Agency has indicated it plans to conduct these additional inspections prior to an Advisory Committee meeting and completion of their review. Due to the timing of the additional inspections, Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015. Merck will continue to work with the FDA as it completes its review. . . .

Alas -- no luck of the Irish there. We had mentioned this scheduled FDA Advisory Committee meeting at the beginning of the month. Oh well. What a tortured path this operating suite drug candidate has endured -- largely due to legacy Schering mismanagement of the studies, and miscalculations in the FDA filing strategy, in that legacy law department. So it goes. Maybe 2016 will be its year. It feels a lil' like my. . . Cubs. Smile.

Thursday, March 12, 2015

Well -- Apple Moves At Lightning Speed, It Seems: UPDATED "Informed Consent" Guidelines For Stanford Med App

Barely eight hours ago, we wrote about the "brave new world" of clinical trial recruiting. . . via an ingeniously simple and elegant iPhone App -- released just Monday. Tonight, AppleInsider is reporting that Apple has already tightened its developer guidelines to address the patient confidentiality and informed consent concerns that FDA and other regulators around the globe might justifiably articulate.

From those just-revised Apple Developer Guidelines, then:

. . .27. HealthKit and Human Subject Research

27.1 Apps using the HealthKit framework or conducting human subject research for health purposes, such as through the use of ResearchKit, must comply with applicable law for each Territory in which the App is made available, as well as Sections 3.3.28 and 3.3.39 of the iOS Developer Program License Agreement

27.2 Apps that write false or inaccurate data into HealthKit will be rejected

27.3 Apps using the HealthKit framework that store users’ health information in iCloud will be rejected

27.4 Apps may not use or disclose to third parties user data gathered from the HealthKit API or from health-related human subject research for advertising or other use-based data mining purposes other than improving health, or for the purpose of health research

27.5 Apps that share user data acquired via the HealthKit API with third parties without user consent will be rejected

27.6 Apps using the HealthKit framework must indicate integration with the Health app in their marketing text and must clearly identify the HealthKit functionality in the app’s user interface

27.7 Apps using the HealthKit framework or conducting human subject research must provide a privacy policy or they will be rejected

27.8 Apps that provide diagnoses, treatment advice, or control hardware designed to diagnose or treat medical conditions that do not provide written regulatory approval upon request will be rejected

27.9 Apps conducting health-related human subject research must obtain consent from participants or, in the case of minors, their parent or guardian. Such consent must include the (a) nature, purpose, and duration of the research; (b) procedures, risks, and benefits to the participant; (c) information about confidentiality and handling of data (including any sharing with third parties); (d) a point of contact for participant questions; and (e) the withdrawal process. . . .

Oh my -- it isn't often that I get caught completely slack-jawed by the advancing pace of tech, but tonight I confess -- I am agape. Maybe I'm just getting old, but it sure seems that the world moves so quickly these days. [Not entirely rhetorically -- I wonder whether both Stanford and Apple received calls from FDA staffers today, post the Bloomberg story and the AppleInsider note, earlier in the week.] Sleep well, one and all!

Drug Discovery -- In Entirely New Places? "Merck, Do Take Heed."

Well, it is truly a brave new world. How so?

I see this morning that the Stanford University Medical Research iPhone App garnered 10,000 patient volunteers in its first two nights of availability in the App Store (to conduct large cardiovascular studies).

In the old world, to get 10,000 patients enrolled in a CV study, one would expect that it would take over a year -- and well north of $2 million, in expenses -- just to get a CRO to find that many, and sign them to required informed consent forms. . . before even beginning a study. So, even if we may quibble about how perfect a match these 10,000 iPhone users will be -- compared to the overall populations involved -- that it was accomplished essentially for free -- and in 48 hours -- is positively mind-bending.

As if that weren't enough, I just read that my favorite lil' genome-mapping-by-spit company, 23andMe (the Google non-affiliated-affiliate!) has just signed a Genentech executive to begin. . . drug discovery efforts, using the vast database of genomic information the company now holds. I'll note that he must have gotten a release under his non-compete from Genentech, because 23andMe already has agreed to collaborate with Roche (the parent), through Genentech -- using the 23andMe database for. . . you guessed it -- drug discovery. In fact, this same executive apparently spear-headed that deal. Small world.

This is entirely fascinating -- from Bloomberg -- more later this afternoon:

. . . .23andMe Inc., the Google Inc.-backed genetic-testing startup that popularized a $99 DNA spit test, will expand from screening people for diseases to inventing new medicine to cure them.

The Silicon Valley company has recruited a top biotechnology executive to help. Richard Scheller spent almost 15 years at Genentech, heading research and early development at the company that invented pioneering cancer drugs Herceptin and Avastin. He’ll lead 23andMe’s new therapeutics group.

It’s the latest evolution for 23andMe, which went from a seller of novelty ancestry kits to one of the world’s biggest repositories of genetic data, doing business with major pharmaceutical companies like Pfizer Inc. and Genentech. . . .

We will of course keep the readership posted. Much more shortly above now, but this is. . . a potential game changer.

Wednesday, March 11, 2015

Keytruda® Early Access In UK For Melanoma; Derek Lowe On R&D Shakeouts (Cubist Version)

Kenilworth this morning announced -- and the gent Ed Silverman duly noted -- that Keytruda® is the first candidate in the United Kingdom to receive an MHPRA pre-clearance "early access" to therapy (likely at small or no price) nod, for patients with advanced melanoma only. That is smallish good news, for Merck -- at least in comparison to BMS's news.

Separately, Derek Lowe at Corante has been lamenting of late the R&D cuts we've all been reading about -- including the Cubist Lexington, Massachusetts ones.

But this morning, he offers us the flip-side -- the quite correct view that this is a very exciting time for science -- cancer researchers, in particular. And he is right, big market disrupting advances lead to frictional dislocation of resources. . . including human capital. Here is a bit of Derek Lowe's fine analysis -- do go read it all:

. . . .That's just one therapeutic area, although it's a big one. There are others advancing as well. That's the frustrating part, in a way - coming into this field de novo, you'd look around and see so many opportunities that you wouldn't know where to start. But many of the existing businesses (and in some cases, existing business models) are having a heck of a time fitting in. Running an organization the size of a Merck or a Pfizer, with those expenses and those legacy commitments and that overhead, really is a beastly job. But no business is owed some sort of right to always exist in its present form. Business-wise, this is an ugly period. Scientifically, it's really quite good. Bridging those two, now - that's where all the clanging noises are coming from. . . .

Our thoughts are with the affected scientists' families -- but we do agree, we will collectively likely look back a decade or two from now, and say. . . this was the turning point, on cancer. That's heady stuff. So. . . onward.

Tuesday, March 10, 2015

Barclays To Host Merck's Rob Davis Tomorrow -- In Miami

Well, at least the weather will be nicer than. . . Boston.

He's not likely to make any real news in Miami tomorrow, but we'll likely listen in just the same. [I suppose he might comment on the NSCLC FDA approval for BMS's Opdivo® -- and, perhaps, Merck's catch-up plans.] We may liveblog any real news:

. . . .Merck announced today that Robert Davis, executive vice president and chief financial officer, Merck, is scheduled to present at the Barclays Global Healthcare Conference in Miami on March 11, 2015 at 8:00 a.m. EDT. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation. . . .

We will -- as ever -- keep the readership posted. [Housekeeping note: Now that the UN Conference on "Every Woman; Every Child" has concluded, I've removed the post that linked directly to that streaming video feed. For future reference, it is]

Undercutting Even The Laudable PATH Initiative, Bharat Offers India A $1/Dose Version Of Merck's RotaTec®

Almost exactly four years ago today, I featured a story about Merck introducing the RotaTec® rotavirus vaccine into India -- at an affordable price (in local Rupees) -- and suggested Mr. Frazier was a visionary for doing so.

It seems that, four years on -- much as we saw yesterday, in the Sovaldi®/Bangladesh story -- local commerce has vaulted well ahead. . . of charity. And that's a good thing, globally.

From FiercePharma's fine story, this morning, then:

. . . .Back in 2011, Indian company Bharat Biotech pledged to offer its rotavirus prospect at a price that undercut even discounted vaccines from GlaxoSmithKline and Merck. Now, it's ready to make good on its promise.

The [company] has rolled out Bharat's three-dose vaccine, Rotavac, at a rate of around 60 rupees--or just under one U.S. dollar. . . .

[I]t's Bharat's new manufacturing process that consumers can thank for Rotavac's low price. The biotech has spent about $20 million to construct new facilities and supporting infrastructure at its Genome Valley plant, which boasts a capacity of 300 million doses per year, it said in a release. . . .

My March 2011 backgrounder may be found here. Onward, on a foggy but temperate Tuesday.

Monday, March 9, 2015

More Granularity, On What BMS's NSCLC FDA Opdivo® Nod Might Mean In 2015 Through 2017

An erstwhile anonymous commenter remarked last week that perhaps the FDA nod to Opdivo® would not mean too, too much to Merck's Keytruda® in NSCLC, longer term. I suppose it may be that the world is changing underfoot (wouldn't be the first time that's happened to me!), but it had always been my perception that -- in oncology at least -- it tends to be "winner take all". The below reiterates that view.

Of course, I do think there will be perhaps $5 to $7 billion in Keytruda market proceeds for Merck (per year), working into 2018 and beyond. However, I do think in the near term, BMS has scored a vast win, here -- by nailing an inroad to NSCLC first -- by as much as 9 to 12 months, over Kenilworth.

And I do think -- as the below Bloomberg article intones, oncology is. . . different. Both as to price points -- and as to prescribing patterns -- where (as here) there is a clear survival benefit. A bit, then -- from the Bloomberg story of this afternoon:

. . . .That’s because the FDA’s practice of approving drugs by each cancer type and stage of disease. So even if two cancer drugs are similar on paper, they may still not compete directly because they are approved for slightly different uses.

Another factor that helps keeps pricing up is that cancer doctors tend to exclusively prescribe the drug that is perceived to have the most efficacy for each particular cancer type, even if the advantage is narrow.

In oncology, it tends to be winner take all,” Evans said. “Whoever has the best efficacy will get all the sales, and that really preserves the pricing power. . . .”

I still think the commenter has a fine longer term (circa 2018 and beyond) point. And, as much as I hate to say it, once Opdivo starts posting results in lung cancer, inside the oncology wards, day by day -- those docs are reasonably likely to write off label for it -- and second line vs. third line will become a blurred line, at best. In sum, I just think it is hard to overestimate the significance of Opdivo's FDA NSCLC nod, last week. For what it is worth.